QC ANALYST (Level 2)

Job Description

ABOUT SHIELDS PHARMA INC.<BR><BR>Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.<BR><BR>We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance.<BR><BR>Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.<BR><BR>Our people are at the heart of everything we do.<BR><BR>You can count on;<BR><BR> Safety as our first core value,<BR> Integrity,<BR> Accountability, and<BR> Continuous Training and skill development.<BR><BR>POSITION TITLE: QC ANALYST (Level 2) Full-time<BR>REPORTS TO: Director of Laboratory Operation<BR><BR>POSITION SUMMARY:<BR><BR>The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for analyzing laboratory raw material, in-process, and finished products samples using various chemical and instrumental techniques, in accordance with compendial; USP, BP, EP, and JP methods and specifications and established in-house testing methods, while under minimum supervision.<BR><BR>The Quality Control Analyst is responsible to operating, maintaining, performing and basic troubleshooting of analytical instruments, including; Dissolution, HPLC, UPLC, LC/MS, GC, GC/MS, ICP-MS, etc.<BR><BR>ESSENTIAL FUNCTIONS<BR><BR> Perform raw material, in-process, finished product, and stability sample testing using instrumental analytical, wet chemicals, and physical analytical methods and techniques following the written procedure or compendial methods.<BR> Prepare analytical equipment for experiments; Including reagents, standards, test solutions, and mobile phase as required by the test procedure.<BR> Perform analytical method Transfer, Verification, Validation and Stability testing.<BR> Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines<BR> Ordering general lab supplies (chemicals/non-chemicals) when required.<BR> Document analytical test results in lab notebooks; Ensure the data generated is accurate and meets the specifications, report results on the testing worksheets (finished products and raw materials) according to standard operating procedures in a timely manner, meeting specified deadlines.<BR> Maintain laboratory lab-books, equipment logbooks, and trackers on daily basis in accordance with department policies and procedures.<BR> Demonstrate sound knowledge of Pharmaceutical Compendial (i.e., USP, BP, EP, JP, etc.) General Chapters methods<BR> Effectively manage the prioritization to meet multiple goals and timelines.<BR> Demonstrate a strong understanding of cGMP, cGLP, Health Canada, FDA, ICH, and other regulatory guidelines<BR> Be able train new or existing personnel as identified by QC management.<BR> Notify any aberrant/OOS/OOT results to QC management and participate to investigate results following the SOP.<BR> Conduct laboratory instruments qualification, calibration, and preventive maintenance when requested<BR> Be able to work in a collaborative, fast-paced environment.<BR><BR>POSITION REQUIREMENTS : (Work Status, Qualification, Knowledge, and Experience)<BR><BR> Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.<BR> Must be living in Canada, preferably in Toronto area<BR> Minimum M.Sc. or B.Sc. degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines with at least of 4 years direct hands-on experience working in pharmaceutical disciplines.<BR> Solid knowledge and expertise (including operation, Qualification, trouble-shooting, and maintenance) working with laboratory instrumentation such as Dissolution, HPLC, GC, ICP-MS, UV-VIS, FT-IR, TOC, TLC, KF, etc.<BR> Familiarity to LC/MS/MS instrumentation and Nitrosamine impurity analysis would be an advantage<BR> Possess extensive experience and in-depth technical knowledge in the method validation, and application of analytical methods used to support pharmaceutical product development and quality control. This includes a strong focus on assay determination, related substances (impurities) analysis, and residual solvents (organic volatile impurities) testing, aligned with ICH, USP, EP, and regulatory expectations.<BR> Well versed in understanding USP, BP, EP, and JP, methods and specifications.<BR> In-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.<BR> Strong attention to detail<BR> Strong problem solving and analytical skills including decision analysis and implementation<BR> Computer Proficiency with MS office (Excel, Word, PowerPoint), Spreadsheets, etc.<BR> Strong ability to function as a team member; ability to communicate effectively with team members and other plant personnel, both verbally and in writing<BR> Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.<BR> Be punctual, team player, fast learner, and have strong Interpersonal and communication skills.<BR><BR>HOW TO APPLY<BR><BR>Please reference QC Analyst (Level 2) in subject line and submit resume with cover letter to <BR><BR>We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above. Kindly refrain from applying if you are not qualified.<BR><BR>We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.<BR><BR>No phone calls please.